At a glance
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Molecular Mechanisms of Disease Progression and Renoprotective Pharmacotherapy in Children With Chronic Renal Failure
In Brief
A Phase 3 clinical trial evaluating ACE Inhibition, Intensified Blood Pressure Control, and 1 other intervention for Children and 4 related conditions. Completed, enrolled 400 participants across 33 sites in 12 countries.
Detailed Summary
In children with chronic kidney disease, progression to end-stage renal failure is associated with high patient morbidity and poor quality of life. In adults, inhibition of the renin angiotensin system (RAS) slows down the rate of renal failure progression. This concept is as yet unproven in children, in whom chronic renal failure (CRF) is more commonly due to hypo/dysplastic malformations than to acquired glomerulopathies as typical for adult chronic kidney disease. The current project aims at assessing the genetic and molecular mechanisms and cardiovascular consequences of progressive CRF and to develop a strategy of pharmacological renoprotection in children.
Study Details
Timeline
Interventions
ACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects.
Any antihypertensive drugs except ACE inhibitors and angiotensin receptor blockers will be allowed.
In patients who show persistent or breakthrough proteinuria at the end of the initial study period, telmisartan (50 mg/m²/day) will be added to the existing medication.